Work

Phase 1 study of AYP-101 (soybean phosphatidylcholine): safety, pharmacokinetics, and lipid profile effects for reducing submental fat

Year: 2024

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Background Excessive submental fat under the chin is a known aesthetic concern because of its negative impact on facial appearance and psychological well-being. AYP-101 is a newly developed injectable agent containing 93% soybean phosphatidylcholine (SPC) designed to reduce submental fat. We conducted a phase 1 study to evaluate the safety, pharmacokinetic (PK), and lipid profile effects of AYP-101. Methods This study was a randomized, double-blind, placebo-controlled, single-dose, two-cohort trial. Participants were randomized into groups receiving 250 mg of AYP-101, 500 mg of AYP-101, or placebo at a 9:9:8 ratio across both cohorts. Safety was assessed through standard clinical evaluations. Blood samples were collected up to 144 h postdose in cohort 1 and up to 48 h postdose in cohort 2. The PK parameters were calculated via noncompartmental analysis. Results All 26 randomized subjects completed the study. There were 72 solicited adverse drug reactions (ADRs) reported by 20 subjects, all of which were mild. The most common ADRs were injection site pain and bruising. No clinically significant differences in safety, PK, or lipid profiles were observed between the dose groups. Conclusions AYP-101 appears to be a safe candidate for treating submental fat, with localized reactions and no systemic exposure at single subcutaneous doses of up to 500 mg. Trial registration: ClinicalTrials.gov NCT05476094

Source: Lipids in Health and Disease

DOI: 10.1186/s12944-024-02387-4

Authors: Hyun Joon Lee, Xu Jiang, A. M. Abd El-Aty, Ji Hoon Jeong, Jae-Yong Chung